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Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00316719
First received: April 19, 2006
Last updated: October 1, 2009
Last verified: October 2009

April 19, 2006
October 1, 2009
January 2006
January 2008   (final data collection date for primary outcome measure)
Mean Change From Baseline in Hepatitis B Virus (HBV) DNA at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
Change in serum HBV-DNA level from baseline to week 52
Complete list of historical versions of study NCT00316719 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With HBV DNA Loss (<400 Copies/mL) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Time to Onset of HBV DNA Loss (< 400 Copies/mL) [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Hepatitis B e Antigen/Antibody (HBeAg/Ab) Seroconversion at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Time to Onset of HBeAg Loss [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
  • Time to Onset of HBeAg/Ab Seroconversion [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Hepatitis B s Antigen (HBsAg) Loss at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Hepatitis B s Antigen/ Antibody (HBsAg/Ab) Seroconversion at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Mean Alanine Aminotransferase (ALT) Level at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Time to Onset of ALT Normalization [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
  • Rate of Emergence of Resistant Virus at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Evaluation of HBV-DNA level and other virus markers at week 52
  • ALT level and proportion of patients achieving ALT normalization at week 52,and time to onset of confirmed serum ALT normalization.
  • Emergence rate of resistant virus
Not Provided
Not Provided
 
Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients
Phase III Study of Adefovir Dipivoxil Tablets in Patients With Compensated Chronic Hepatitis B -Comparative Study Against Lamivudine-

This study is designed to compare the efficacy and safety of adefovir dipivoxil 10 mg with lamivudine 100 mg in Japanese patients with compensated chronic hepatitis B over 52-week periods.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Hepatitis B
  • Drug: LAM group
    Subjects took one LAM 100mg tablet orally once daily and one ADV placebo tablet orally once daily.
    Other Name: Lamivudine
  • Drug: ADV group
    Subjects took one ADV 10mg tablet orally once daily and one LAM placebo tablet orally once daily.
    Other Name: adefovir dipivoxil
  • Experimental: Adefovir Dipivoxil (ADV)
    Intervention: Drug: ADV group
  • Active Comparator: Lamivudine (LAM)
    Intervention: Drug: LAM group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
January 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Have compensated chronic hepatitis B.
  • Have not been treated with anti HBV agents with antiproliferative activity against. However, previous Interferon (IFN) therapy is permitted.
  • Ability to read, understand, and sign the informed consent.
  • Have a positive serum HBV-DNA >= 1,000,000 copies/mL and ALT level 50-500 U/L

Exclusion criteria:

  • Having or suspected of having liver cancer.
  • Co-infected with Hepatitis C virus (HCV) or Human Immunodeficiency virus (HIV).
  • Autoimmune hepatitis.
  • Received any previous transplantation or having a plan for any transplantation.
  • Existence of any serious complication, except hepatitis B.
Both
16 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00316719
ADF105220
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP